Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)
To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice.
To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice.
To compare the percentage of patients achieving HbA1c< 7% in each treatment group.
To compare hypoglycaemic events (minor, severe and nocturnal) between groups.
To compare average insulin dose between groups.
To compare PRO (patients' reported outcomes) between groups.
To compare mean changes in body weight between treatment groups.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 24 Weeks, Randomized, 2 Arms, Controlled, Multi-centre, National, Open-labeled, Parallel Study in Insulin naïve Patients With Type 2 Diabetes to Compare a Lantus Titration Algorithm vs. Physician's Standard Practice|
- Mean difference in HbA1c (efficacy) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Minor, severe and nocturnal Hypoglycaemic events (safety) [ Time Frame: from the begining of the treatment up to 5 days after the end of the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Active Comparator: A
This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.
Drug: Insulin Glargine
In the group following the algorithm, fasting SMBG will be asked 3 times a week until FBG<100 mg/dl is achieved. Afterwards, 1 fasting SMBG will be asked weekly. Pre-prandial SMBG will be performed at the discretion of the physician.
For the group following the algorithm, during the titration period, weekly telephone contacts will be required and a minimum of 4 visits to the clinic.
Active Comparator: B
This is the control group, following the physician's standard practice.
Drug: Insulin Glargine
For the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG.
|Sanofi-aventis administrative office Argentina|
|Buenos Aires, Argentina|
|Study Director:||Cristian von Schulz-Hausmann||Sanofi-aventis administrative office Argentina|